Depression disorder is one of the most common mental disorders in the human beings. The research by World Health Organization (WHO) indicates that the incidence of depression in the world is about 3.1%. In western developed countries, the incidence of lifelong depression ranged from 6% to 8%. Along with the gradual aging of the population, the incidence of depression in the population of more than 60 years old would be as high as 20%-50%. It was predicted that the incidence of depression in these countries would rise to about 8%-10% in 2005. It was indicated in World Health Report, 2002 issued by WHO that depression had been the fourth severest disease in the world, and would become the second severest disease next to heart attack in 2020 (ZHU Ziqing et al, Key of Diagnosis and Treatment for Depressive Disorder, Phoenix Science Press, 2003, p 2-3).
The pathogenesis of depression is very complex, and the occurrence of depression may relate to nerve functional unbalance of monoamine-type neurotransmitters in brain. The hypotheses of noradrenalin and 5-hydroxytryptamine are widely applied to the biological pathogenesis of depression (J I Jianlin et al, Analysis of Somatic Symptoms of Depression and Relative Factors, Chinese Mental Health Journal, 2002, 16(9):605-608).
At present, depression is treated with medication, psychotherapy, electroshock therapy and the like, and medication is still the primary means. The long-term administration of the western medicine—antidepressant may result in adverse reactions in nerve system, anticholinergic, cardiovascular aspects. Although novel antidepressants (e.g. SSRI, NaSSA, SNRI and the like) have better safety and tolerance, many patients cannot afford the treatment, especially the long-term treatment due to their higher price, so that the patients' compliance is decreased and the treatment is affected.
The treatment of emotional diseases with traditional Chinese medicine has a history of about 2000 years. The clinical manifestations of depression indicate that the disease may be categorized into Syndrome of Melancholia (Yu zheng), Hysteria (Zangzao), Lily Disease (Baihebing), Insomnia and the like in traditional Chinese medicine. The diagnosis and treatment of this disease should follow the same for “Syndrome of Melancholia (Yuzheng)” in traditional Chinese medicine. In recent years, some traditional Chinese medical formulae are applied in the treatment of depression and proved to have good therapeutic effects. Moreover, many studies demonstrate that the traditional Chinese medicinal formulation may improve the behaviors of animal models for depression and be favorable to the central nerve transmitters. Under the concept of wholism, treatment of depression with traditional Chinese medicine is based on overall analysis of symptoms and signs, the cause, nature and location of the illness and the patient's physical condition according to the basic theories of traditional Chinese medicine, which has definite and sustainable therapeutic effects, safety, and better patient's compliance, especially is adaptable to patients suffering from minor or moderate depression with the adjustment of life styles. The traditional Chinese medicine is safe, effective and economical, which also satisfies the requirements for therapeutic effect on patients suffering from depression. (YANG Shiyou et al, Effects of Jie Bai You Oral liquor on Behaviours of Rat Models for Depression and the Central Nerve Transmitters, Chinese Journal of Basic Medicine in Traditional Chinese Medicine, 2000, 6(11):56-59).
According to the theory of traditional Chinese medicine and Zhang Zhong-jing's (a famous doctor in Eastern Han Dynasty of China) academic ideology on the treatment of emotional diseases, the inventor profoundly studies how emotions lead to depression, and emphasizes the fact that such emotional factors as depression, gloominess, sadness or over-worry will lead to liver failing to maintain the normal flow of Qi, dysfunction of the spleen in transport and heart-spirit support loss, so as to render multi-entrails functional disorder. The inventor also points out that stagnation of liver-Qi leads to stagnant-fire, which influences to the body fluid and further leads to sputum, thus results in the pathogenesis of Qi stagnation, sputum accumulation, and fire disturbance. With clinical experiences of medication for the treatment of mental and neurological diseases, the inventor contrives a traditional Chinese medicinal composition to effectively alleviate of mental depression and relieve restlessness, and provides a novel traditional Chinese medicine formulation of the present invention, which has excellent therapeutic effects and is safe for patients suffering from depression. Up to now, there is no report relevant to the traditional Chinese medicinal composition of the present invention and the formulation thereof.